Z-2060-2010

Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems...

Name: Z-2060-2010 Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2010-06-11
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2010-06-11 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature... on 2010-06-11. The reason FDA records is "The HX2 Temperature Management System mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2060-2010
Status: Terminated
Initiated: 2010-06-11
Posted: 2015-06-26
Terminated: 2011-04-13
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: The HX2 Temperature Management System mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, TERUMO Cardiovascular Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 11, 2010, to the consignees. The letter describes the product, reason for correction, what to do in the event of failure, potential hazard, correction, affected population and action to be taken by the customers. The customers are instructed to review the correction notice, assure that all users are aware of this notice, and complete, sign and fax the attached Customer Response Form to Terumo CVS Customer Service at 800-292-6551. The Terumo CVS Customer Service Dept. will contact you upon receipt of the Customer Response Form to schedule the replacement. The firm plans to inspect and correct all units in the field within 5 months. We encourage you to contact Terumo CVS Customer Service at 1-800-521-2818, Monday-Friday, 8 AM-6 PM EST, with any questions or concerns.
Quantity in commerce: 100
Distribution: Nationwide Distribution: AR, CA, CO, CT, FL, HI, IA, IL, KS, LA, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA and WI.
Product codes and lots: Serial numbers 0001-0003, 1001-1084 and 1101-1116.

Product code DWC

K071521Class IITerumo Hx2 Temperature Management SystemTerumo Cardiovascular Systems Corp. / cleared 2007-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)